EP1250171B1 - Valve hemostatique - Google Patents

Valve hemostatique Download PDF

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Publication number
EP1250171B1
EP1250171B1 EP01946796A EP01946796A EP1250171B1 EP 1250171 B1 EP1250171 B1 EP 1250171B1 EP 01946796 A EP01946796 A EP 01946796A EP 01946796 A EP01946796 A EP 01946796A EP 1250171 B1 EP1250171 B1 EP 1250171B1
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EP
European Patent Office
Prior art keywords
valve
hemostasis
gasket
proximal
distal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP01946796A
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German (de)
English (en)
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EP1250171A2 (fr
Inventor
Xiaoping Guo
Richard Stehr
Daniel J. Potter
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St Jude Medical LLC
Original Assignee
Daig Corp
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Publication date
Priority claimed from US09/491,221 external-priority patent/US6551283B1/en
Application filed by Daig Corp filed Critical Daig Corp
Publication of EP1250171A2 publication Critical patent/EP1250171A2/fr
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Publication of EP1250171B1 publication Critical patent/EP1250171B1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/064—Slit-valve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/0653—Perforated disc
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0686—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof comprising more than one seal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M39/0606—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof without means for adjusting the seal opening or pressure

Definitions

  • This invention relates to medical devices and instruments. More particularly, this invention relates to hemostasis valves and hemostasis cannula units containing a hemostasis valve, wherein the hemostasis valve is comprised of two separate valve gaskets, each with the same shape, which are reversed in position, but joined together within the valve housing of the hemostasis cannula.
  • the introduction of catheters into blood vessels for a variety of purposes such as coronary angiography has been known for many years.
  • Several techniques for introducing these catheters into the vasculature of the human body are available.
  • One such technique is the cut-down method, while another is the Seldinger technique.
  • the Seldinger technique includes surgically opening a vein or artery with a needle, inserting a guidewire into the vessel through the lumen of the needle, withdrawing the needle, inserting over the guidewire a dilator which has passed through an associated sheath containing a hemostasis valve, removing the dilator and inserting a catheter through the hemostasis valve and sheath into the blood vessel.
  • hemostasis valves A wide variety of hemostasis valves are known in the prior art.
  • a guidewire is inserted through most hemostasis valves, because most guidewires are so small relative to the catheters which may also be employed, it is often difficult for the valve to seal adequately against the backward pressure of blood, while at the same time permitting easy insertion of much larger diameter catheters into the vasculature.
  • This problem is particularly acute with catheterization procedures involving arterial introduction where there is a high reverse pressure of blood. In these arterial procedures, blood can squirt out when the guidewire is introduced through the hemostasis valve. Excessive blood leakage may be extremely dangerous to patients and a contaminant to the operating room and medical personnel.
  • hemostasis valves are designed for use with only one size of catheter. It has often been difficult to employ a single type of hemostasis valve with catheters of widely varying diameters because adequate sealing around the catheter walls cannot be achieved by these hemostasis valves.
  • Cardiac catheter introducers used during coronary procedures often contain a hemostasis valve that is mounted in the valve housing or hub, which is secured on the proximal end of the introducer.
  • Such an introducer is conventionally used to facilitate the insertion of catheters and guidewires into the vascular system of a patient, while minimizing injury to the patient at the access site and improving the patient's comfort during the cardiac catheterization procedure.
  • An introducer is particularly necessary where one or more treating catheters of varying diameters are inserted into and removed from the patient's vessel repeatedly as often occurs during angiographic procedures and angioplasty. The mere presence of the catheter introducer and the insertion of different size catheters through the introducer often causes bleeding during cardiac catheterization procedures.
  • a high performance hemostasis valve is therefore needed to seal against the leakage of blood out of or around catheters and guidewires having varying diameters as they enter an artery or other blood vessel.
  • the hemostasis valve must also prevent the introduction of air into the artery or blood vessel of the patient when one or more than one of the elongated catheters or guidewires are withdrawn from the introducer. In addition, the valve must remain sealed when there is no medical device passing through the valve.
  • the requirements for a useful hemostasis valve include at least the following: (a) the valve is always sealed when no elongated cylindrical medical device is introduced through it; (b) the insertion and retraction forces must be minimal when larger diameter catheters (such as those larger than about 9 F (3 mm)) are introduced into the valve; (3) in contrast, the valve must maintain good sealability when small diameter guidewires (such as those down to 0.014 in. (0.35 mm)) pass through its passageway; and (4) to the greatest extent possible, the deformation of the valve should be in a radial direction instead of an axial direction to prevent the transmission of air into the blood stream.
  • Type I Numerous hemostasis valves are known which can be classified in three major groups.
  • Type I as disclosed, for example, in U.S. Patent No. 5,041,095 and 5,176,652, contain a pair of disc-like gaskets of approximately equal thickness.
  • Each gasket has a Y-shaped opening cut into the gasket radially extending from its center forming three (3) slits, each located at an angle of about 120 degrees from the other slits.
  • Each slit penetrates the gasket from one end face to the other end face.
  • the two Y-shaped slits of the respective gaskets are mounted in a position opposite to one another in the valve housing.
  • DE 297 01 600 discloses a two disk hemostasis valve, wherein each disk (1, 11) contained a pair of tabs (3, 3') extending outward from the surface of the disk and a pair of slots (4, 4'). However, these tabs (3, 3') do not extend downward into the slots (4, 4') of the complimentary disk (1').
  • Type II hemostasis valves as disclosed, for example, in U.S. Patent Nos. 4,626,245; 4,629,450; 5,114,408; 5,149,327 and 5,167,637 and utilize a single sealing disk.
  • This disk generally has a first slit that opens at only one end face and a second slit that opens at only the other end face.
  • Other types of single disk hemostasis valves with different shapes for the opening through that disk are disclosed, for example, in U.S. Patent Nos. 4,705,511 (see Figure 4); 4,798,594 and 4,895,565.
  • Type III hemostasis valves as disclosed, for example, in U.S. Patent Nos. 5,149,327; 5,207,656 and 5,520,655, are similar to Type II hemostasis valves, but differ in that only one slit (Y-shaped or + -shaped) penetrates from one end face to the other end face of the gasket.
  • the slit may be perpendicular to the body of the valve or it may be spiral cut to form a downwardly spiraling cut, as disclosed ih U.S. Patent Nos. 5,520,655, 4,789,594, and 4,895,565.
  • hemostasis valves are disclosed in various patents such as in U.S. Patent Nos. 4,610,655; 4,909,798 and 5,125,903. However, these hemostasis valves are generally designed for use with a particular size of medical device.
  • the insertion force may also be a problem.
  • these valves often do not seal against the leakage of blood when a small-diameter guidewire passes through its slit passageway. Further, the restitutive force created by the retraction of larger-diameter catheters may cause the introduction of air into the blood stream.
  • U.S. Patent No. 5,520,655 discloses a medical device wherein the valve is pre-deformed in an axial direction opposite to that of the insertion force.
  • the axial deformation induced by the insertion of an elongated medical device is compensated for by this pre-deformation.
  • the actual deformation during insertion seems to be radial to the valve, thus improving the sealability of the valve.
  • the insertion force may increase due to this pre-deformation, and the restitutive force due to the retraction of the elongated cylindrical member may still allow the seepage of air into the blood stream.
  • U.S. Patent No. 4,917,668 suggests the use of springloaded resilient gasket valve members with one or more spring elements augmenting the natural resilience of the sealing gasket material to improve sealability.
  • the insertion force increases with incorporation of metal springs.
  • U.S. Patent No. 5,125,903 discloses the use of concave and convex cusp-shaped surfaces to form the thinned central region of the valve, through which the short intersecting slits extend at a 45 degree angle to the 90 degree line of intersection.
  • hemostasis valves described above represent departures from, and attempts to overcome deficiencies in, the flat disk-shaped gaskets involving reduced diameter holes, slits and crossed slits therethrough to accommodate elongated cylindrical medical devices passing through the valve.
  • improvements are still necessary to hemostasis valves to overcome problems of the prior art valves.
  • a universal hemostasis valve which exhibits high performance in sealing against the leakage of blood, limits the backflow of air into the vessels and eases insertion and retraction of elongated cylindrical medical devices of varying diameters.
  • This hemostasis valve may be reliably used with a wide variety of both large catheters, up to about 9 F (3 mm), and small guidewires, down to 0.014 in. (0.35 mm).
  • It is a further object of the invention to disclose a hemostasis valve comprising a proximal valve gasket and a distal valve gasket, wherein each of the valve gaskets contains at least one positioning protrusion and at least one positioning slot which interact with each other to orient the two valve gaskets in a particular position relative to each other.
  • It is a still further object of the invention to disclose a hemostasis valve comprising a pair of valve gaskets, wherein the center of each valve gasket is very thin in relation to the overall thickness of the valve gasket.
  • a hemostasis valve comprising a pair of valve gaskets, each containing a slit, wherein each of the slits is angled at an angle of from 85 degrees to about 30 degrees to the position of the surface of each valve gasket.
  • It is a still further object of the invention to disclose a hemostasis valve comprising a pair of valve gaskets, wherein each contains a conical receiving area and a guiding hole to guide medical devices through the hemostasis valve.
  • It is a still further object of the invention to disclose a hemostasis valve comprising a pair of valve gaskets which maintain substantial contact against each other when a medical device passes through the hemostasis valve.
  • It is still further object of the invention to disclose a hemostasis valve comprising a pair of identical valve gaskets joined together, wherein the entry face of the proximal valve gasket and the exit face of the distal valve gasket contain axially compressible concentric rings.
  • a hemostasis cannula unit including a valve housing, a cap and a hemostasis valve, wherein the hemostasis valve comprises a pair of identical valve gaskets, each containing at least one positioning protrusion and at least one positioning slot which interact with each other to orient the two valve gaskets to a particular position relative to each other.
  • This invention involves a hemostasis cannula unit, which includes a longitudinally extended housing having a first and second opposing end, a cap enclosing the first end containing an opening to permit insertion of a dilator or catheter into the longitudinally extended housing, and a hemostasis valve, which consists of a pair of identical valve gaskets compressed together by the valve housing.
  • the invention also involves a hemostasis valve comprised of two separate, identical, valve gaskets, wherein the proximal valve gasket is maintained in a fixed position relative to the distal valve gasket by the use of at least one cooperating positioning protrusion and slot present in each valve gasket.
  • the invention also involves a hemostasis valve comprised of two separate, but identical valve gaskets, wherein the center of each valve gasket is very thin in comparison to the overall thickness of the valve gasket.
  • the invention also involves a hemostasis valve comprised of two separate but identical valve gaskets, each containing a slit, wherein each of the slits is angled at an angle of about 30 to about 85 degrees from the surface of the face of the valve gasket.
  • the invention also involves a hemostasis valve comprised of two separate, but identical valve gaskets, each of which contains a conical receiving area and each of which contains a centering or guiding hole.
  • the invention also involves a hemostasis valve comprised of two separate, but identical valve gaskets, wherein the entry face of the proximal valve gasket and the exit face of the distal valve gasket each contains concentric rings extending from the respective surfaces of the two valve gaskets, wherein these concentric rings are placed under compression when the hemostasis valve is placed within a hemostasis valve housing.
  • the invention also involves a hemostasis valve comprised of two separate, but identical valve gaskets, wherein the sides of each of the hemostasis valve gaskets contains- a beveled edge which extends toward the inside wall of the valve housing when a medical device is inserted through the hemostasis valve.
  • the invention also involves a hemostasis valve comprised of two separate, but identical valve gaskets, wherein the distal face of the proximal gasket and the proximal face of the distal gasket maintain contact with each other when a medical device is inserted through the hemostasis valve.
  • the invention also involves a hemostasis valve comprised of two separate valve gaskets, each of which contains an angled slit wherein the angled slit in the proximal gasket cooperates with a proximal surface of the distal gasket and the angled slit in the distal gasket cooperates with the distal surface of the proximal gasket to effect sealing of the valve upon removal of a medical instrument therefrom.
  • the high performance hemostasis valve (10) of the present invention is preferably incorporated in a hemostasis cannula assembly (70) as shown in Figures 1 and 2, which is used, for example, for various cardiac catheterization procedures in which a dilation catheter or treating catheter advances over a small guidewire into a blood vessel.
  • the hemostasis cannula assembly (70) is formed of five major components, as shown in Figures 1 and 2.
  • the first of these components is the cap (80), which is attached to the proximal end of the second component-the longitudinally extended valve housing or hub (90).
  • the valve housing (90) has proximal and distal opposing openings through which elongated cylindrical medical devices are inserted into and out of the interior of the valve housing or hub (90).
  • the cap (80) and valve housing (90) of the cannula assembly (70) are preferably made from a relatively rigid thermoplastic material, such as a high-density polyethylene or an acrylonitrile-butadiene-styrene copolymer.
  • the cap (80) may be secured to the body (96) of the valve housing (90) by mechanical means using threads, snap fittings, etc. or by gluing, but preferably it is secured by ultrasonic welding or heat adhesion.
  • the third and fourth major components of the hemostasis cannula assembly (70) of the present invention form the hemostasis valve (10) and consist of a proximal valve gasket (20) and a distal valve gasket (40) as shown in Figures 1, 2 and 3.
  • An entry face (21) of the proximal valve gasket (20) contacts the inner surface of the cap (80) of the hemostasis cannula assembly (70) and an exit face (23) of the proximal valve gasket (20) contacts an entry face (41) of the distal valve gasket (40), as shown in Figure 1.
  • An exit face (43) of the distal valve gasket contacts a surface on the interior of the valve housing (90) as shown in Figure 1 to hold the valve gasket (10) securely within the valve housing (90).
  • the valve gaskets (20, 40) are made from a pliant, high elastic polymeric material, such as a silicone rubber, or a thermoplastic elastomer (olefinic, styrenic, polyamide-based, polyester-based, or a hydrocarbon rubber, such as polybutadiene, polyisoprene, or natural rubber), which can readily and repeatedly permit passage of elongated cylindrical medical devices (120) of varying diameters through the hemostasis valve (10).
  • a pliant, high elastic polymeric material such as a silicone rubber, or a thermoplastic elastomer (olefinic, styrenic, polyamide-based, polyester-based, or a hydrocarbon rubber, such as polybutadiene, polyisoprene, or natural rubber)
  • the final major component of the hemostasis cannula assembly (70) of the present invention is the tubular introducer sheath (100) as shown in Figures 1 and 2, which is preferably made of a biocompatible thermoplastic material, such as a high density polyethylene (HDPE), polypropylene, fluoropolymer, polyether block amide (PEBA), polyamide (PA), polyvinyl chloride (PVC), polyurethane-based thermoplastic elastomer or a blend of the aforementioned polymeric materials.
  • a multilayered tubular structure may also be used to co-extrude the introducer sheath (100) using different combinations of the aforementioned polymeric materials.
  • the sheath (100) is inserted within the distal end (94) of the valve housing or hub (90) and is secured in place preferably by heat adhesion or ultrasonic welding to provide an exit from the interior of the valve housing (90).
  • a side port (110) is preferably secured to or formed into the valve housing (90) distal to the hemostasis valve (10), as shown in Figures 1 and 2, to provide for the perfusion and aspiration of fluids through the sheath (100).
  • the introducer sheath (100) maintains the percutaneous opening, or access site to the vasculature, initially made with other devices, such as a hypodermic needle or scalpel, and provides an entrance point for a dilator or obturator, as well as catheters and guidewires.
  • the introduction of the introducer sheath (100) into the blood vessel is accomplished by a dilator advancing over the guidewire, both of which are advantageously passed through the introducer sheath (100) and valve (10).
  • the guidewire and dilator are removed in favor of insertion of the therapeutic catheter system, as shown, for example, in Figure 10.
  • the proximal valve gasket (20) and the distal valve gasket (40) form the hemostasis valve (10) as shown in Figures 1,2 and 3.
  • the proximal valve gasket (20) and the distal valve gasket (40) are assembled by aligning and inserting one or more, preferably two, positioning protrusions (32, 52) located on each of the valve gaskets (20, 40) within one or more, preferably two, positioning slots (34, 54) located on each of the valve gaskets (20, 40) as shown in Figure 3.
  • the hemostasis valve (10) is inserted into the valve housing (90) at its proximal end (92), as shown in Figure 1.
  • the cap (80) is then secured onto the proximal end (92) of the valve housing (90).
  • a guiding cone or conical receiving area (22) of the proximal valve gasket (20) is approximately in alignment with an opening (84) through the cap (80).
  • the entry face (21) of the proximal valve gasket (20) and the exit face (43) of the distal valve gasket each contain elevated concentric rings (30, 50) as shown, for example, in Figures 1, 3, 4 and 6, which are compressed when the hemostasis valve (10) is inserted within the valve housing (90) and secured in place when the cap (80) is secured to the proximal end of the valve housing (90).
  • the pressure against the hemostasis valve (10) compresses it at least about 2 percent and preferably from about 2 to 5 percent within the valve housing (90).
  • proximal valve gasket (20) and the distal valve gasket (40) are preferably formed with an identical shape and structure. Having the same structure obviously reduces the overall cost of manufacture of the hemostasis valve (10). Further, there are many advantages to this structure which are discussed in more detail later. However, for purposes of this discussion, the description of the structure and shape of the proximal valve gasket (20) applies equally to the structure of the distal valve gasket (40).
  • the proximal valve gasket (20) contains a conical receiving area or guiding cone (22) which tapers into a centering or guiding hole (24), as shown in Figures 1, 4, 5A and 5B.
  • the conical receiving area or guiding cone (22) tapers at an angle from about 20 to about 80 degrees, and preferably from about 20 to about 60 degrees from the entry face (21) of the valve gasket (20).
  • the centering hole (24) acts as a sealing neck when a catheter of larger diameter passes through the hemostasis valve (10).
  • the centering hole (24) can be formed in any cross section, consisting with the outer geometry of the medical instruments inserted therein.
  • the cross section of this hole (24) could be rectangular; triangular, elliptical or round.
  • a circular cross section is utilized for the centering hole (24) as shown in Figures 4 and 5A, it is preferred that its diameter be that of the smallest dilator that is utilized with the hemostasis cannula assembly (70).
  • a circular cross section is preferred, as shown in Figures 4 and 5A, such as that which would accommodate a 4 French (1.33 mm) dilator.
  • the guiding hole (24) terminates distally in a flat surface (25).
  • This slit (26) Extending distally from the guiding hole (24) of the valve gasket (20) is the slit (26) of the valve gasket (20), which entirely passes through the remaining portion of the valve gasket (20), to its exit face (23) as shown in Figures 1 and 5A.
  • This slit (26) is preferably a single slit with its proximal end located at or near the center of the guiding hole (24).
  • the width of the slit (26) is from about 0.070 in. (1.8 mm) to about 0.15 in. (3.8 mm), and preferably from about 0.09 in. (2.3 mm) to about 0.12 in. (3.0 mm).
  • slit (26) is preferably cut at an angle from about 5 to about 70 degrees away from being perpendicular to the outer surface (23) of the proximal valve gasket (20). Optimally the angle of this cut is from 44-46 degrees out of perpendicular.
  • the slit (26) is preferably axially centered so that its proximal edge and distal edge are equidistant from the long central axis of the hemostasis cannula assembly (70). Slit (26) is also centered radially.
  • the width of slit (26) (and, correspondingly slit (46)) is preferably greater than the inner diameter of guiding hole (24), the slit extends partially over and partially under conical area (22), leaving two sections (31) of slit (26) visible as shown on Figure 4. (See the corresponding cut sections (51) of the distal valve gasket (40) as shown on Figure 6.) Angling slits (26, 46) in the manner described creates thin regions of elastomeric material at the leading and trailing portions of the slits (26, 46) and, thus makes those areas more responsive to the surface geometry of the medical device (120), which may be placed therein.
  • the slit (26) may extend at a perpendicular angle to the surface of the exit face (23) and to the surface (25) of the guiding hole (24).
  • the exit face (23) of the proximal valve gasket (20) includes a depressed, beveled edge (28), as shown in Figures 5, 5A and 5B, which is angled at an angle from about 20 to about 90 degrees and preferably from about 30 to about 60 degrees from the exit face (23) of the proximal valve gasket (20).
  • the space between the beveled edge (28) of the proximal valve gasket (20) and the inner surface of the valve housing (90) is gradually filled with the expanded material of the proximal valve gasket (20), thereby reducing the difficulty of introducing the medical device through the hemostasis valve (10).
  • the second major component of the hemostasis valve (10) is the distal valve gasket (40), as shown in Figures 6, 6B and 7. It is designed to complement the proximal valve gasket (20) and operate in coordination therewith to provide improved sealing for small guidewires. It is designed with the same shape as that of the proximal valve gasket (20), only reversed, as shown in Figure 3, such that the entry face (41) of the distal valve gasket (40) cooperates with the exit face (23) of the proximal valve gasket (20), as shown in Figure 1.
  • Gaskets (20) and (40) being preferably the same shape has advantages that will be readily apparent. For example, one mold can produce parts that can serve as either gasket. Similarly, the same processes can be used to stock and handle inventory parts.
  • the distal valve gasket (40) also includes a beveled edge (48).
  • This beveled edge (48) of the distal valve gasket (40) works in coordination with the beveled edge (28) of the proximal valve gasket (20). It is angled with a complementary angle to the angle of the beveled edge (28) of the proximal valve gasket (20).
  • the distal valve gasket (40) Near the center of the distal valve gasket (40) is its slit (46), as shown in Figures 6, 6B, 7 and 9, which is preferably placed in a position perpendicular to the position of the slit (26) of the proximal valve gasket (20) when the proximal valve gasket (20) and the distal valve gasket (40) are joined together as shown in Figures 1 and 3.
  • the width of the slit (46) of the distal valve gasket (40) is preferably the same width as is the width of the slit (26) of the proximal valve gasket (20).
  • the slit (46) of the distal valve gasket (40) extends through the distal valve gasket (40) to a guiding, centering or guard hole (44) as shown in Figures 6 and 6B.
  • the guiding hole (44) of the distal valve gasket (40) performs an important function by assisting in the guiding of indwelling medical devices through the hemostasis valve (10), especially curved medical devices. When those curved medical devices pass through the centering hole (24) and slit (26) of the proximal valve gasket (20), the curved medical device may tend to stray from the center of the hemostasis valve (10).
  • the distance that the medical valve must pass through the hemostasis valve (10) be kept to a minimum.
  • the thickness of the hemostasis valve (10) where the medical device passes through the hemostasis valve (10) is kept at a minimum.
  • the thickness of this portion of the hemostasis valve (10) in relation to the overall thickness of the hemostasis valve (10) is kept to a minimum.
  • the thickness of the slit area (between exit face (23) and flat surface (25) and entry face (41) and flat surface (45), respectively) of both the proximal and distal valve gaskets (20, 40) are preferably from about 0.010 inches (0.25 mm) to about 0.03 inches (0.8 mm).
  • This is designated at Figure 6B, reference number 60.
  • the thickness of this slit (46) is designated by number 60 on Figure 7.
  • the longitudinal thickness of the centering hole (44) is approximately the same thickness as is the thickness of the slit (46).
  • the overall longitudinal thickness of the slit area (60) and centering hole (44) in combination which is designated by numeral (62), is preferably from about 0.02 inches (0.5 mm) to 0.06 inches (1.6 mm).
  • the thickness of the proximal valve gasket (20) or the distal valve gasket (40) from their respective entry faces (21, 41) to their respective exit face (23, 43) is considerably thicker than the thickness of the respective slits (26, 46) designated by number 64, or the thickness of the respective slit area (60) and centering holes (24, 44) combined (62).
  • the thickness is measured from its entry face (41) on the proximal side of the distal valve gasket (40) to its exit face (43) on the distal side of the distal valve gasket (40).
  • This thickness, designated by number (64), of the distal valve gasket (40) is preferably from about 0.07 inches (1.8 mm) to about 0.15 inches (3.8 mm).
  • the thickness (60) of the slit (46) of the distal valve gasket (40) is less than about 25 percent of the overall thickness (64) of the distal valve gasket and more preferably from about 10 to about 40 percent of that thickness (64).
  • the split slits (26, 46) formed by the slit (26) of the proximal valve gasket (20) and the slit (46) of the distal valve gasket (40) act as the primary crisscross sealing barrier to prevent the flow of blood and air through the hemostasis valve (10).
  • one or more, preferably two, positioning protrusions (32) are provided in the outer edge (29) of the proximal valve gasket (20) which align with one or more, preferably two, positioning slots (54) present in the outer edge (49) of the distal valve gasket (40), as shown in Figure 3.
  • the respective slits (26, 46) align radially, perpendicularly to each other to assure proper relative position of the distal valve gasket (40) and the proximal valve gasket (20) and to form the preferred crisscross sealing pattern within the hemostasis valve (10), as shown in Figures 1 and 3.
  • the slit (46) of the distal valve gasket (40) is located at a position between the respective positioning protrusions (52), as shown on Figure 7, and is perpendicular to a line formed between the respective positioning slots (54).
  • the proximal valve gasket (20) contains a similar structure for its slit (26) as shown in Figure 5.
  • the gaskets (20, 40) are preferably aligned so that the respective slits (26, 46) align perpendicular to each other the slits (26, 46) may be aligned so that the angle between the slits (26, 46) is as much as 45 degrees out of perpendicular, or more, if desired.
  • This structure of complimentary positioning protrusions (32, 52) and positioning slots (34, 54) in each of the proximal and distal valve gaskets (20, 40) results in the proper alignment of the proximal valve gasket (20) in relation to the distal valve gasket (40) when the two gaskets are joined together.
  • the distance between the inner surface of each pair of positioning protrusions (52), as shown in Figure 7, is slightly less than the inner diameter of the slots (54) provided in the distal valve gasket (40).
  • exit face (23) supports the thinner proximal elastomeric region of slit (46) which, again, retains its ability to conform to the outer diameter of an indwelling medical device.
  • the axial distal edge of slit (46) also has a thin region. This region is thin and pliant to follow the contour of the medical device, but it is urged closed by pressure exerted from a fluid (blood) column in communication with the normally pressurized circulatory system.
  • the three thin elastomeric regions of slits (26 and 46) are not only more responsive to the medical device contours, they more quickly relax from a state of deflection, sometimes constantly for a period of many hours, to completely isolate the blood from the operating room environment. In other words, the thin regions allow the valve (10) to close completely and quickly because they relax to the closed state faster than thicker regions that have been deformed for lengthy periods of time.
  • the entry face (21) of the proximal valve gasket (20) preferably has the same structure and shape as the exit face (43) of the distal valve gasket (40).
  • each of these faces (21, 43) contains one or more concentric rings (30, 50) raised above the surface of the faces (21, 43).
  • concentric rings (30, 50) are raised slightly above the surface of the exit face (43).
  • Each of these concentric rings (30, 50) are put under pressure when the cap (80) is secured onto the valve housing (90) as shown in Figure 1.
  • Figure 8 shows a deformed configuration for the respective slits (26, 46) when an elongated cylindrical member (120) passes through the hemostasis valve.
  • two curvilinear triangle-like interstices (27, 47) are formed at the ends of the respective slits (26, 46).
  • the interstices (27) of the proximal valve gasket and those (47) of the distal valve gasket (40) interweave when a cylindrical member (120) passes through the distal valve gasket (40) and proximal valve gasket as shown in Figure 8.
  • the interweaving of the interstices (27, 47) from the respective proximal valve gasket and distal valve gasket (40) creates a mutual barrier against the leakage of blood through the hemostasis valve. Leakage of blood occurs only if the two neighboring, interweaving interstices (27, 47) are connected. If the diameter of the elongated cylindrical member (120) inserted is too small, the two neighboring interstices (27, 47) may remain connected, dependent on the degree of the radial compression of the hemostasis valve. In such cases, leakage of blood is prevented by the initial radial compression.
  • the diameter of the elongated cylindrical member (120) is too large, it is possible for interweaving interstices of a conventional hemostasis valve to connect, forming a passage for the leakage of blood around the circumference of the catheter. This becomes a more serious problem when the inserted medical device (120) is circumferentially turned by the clinician during the insertion.
  • leakage of blood can be limited or prevented by the complimentary sealing capacity of the guiding holes (24, 44), the diameter of which is smaller than the diameters of some large sized catheters used with the present hemostasis valve.
  • Figure 9 depicts an enlarged distal view of the axial portion of hemostasis valve (10).
  • the axial distal edge of slit (46) can be seen in plan view upon flat surface (45) with its proximal and distal regions depicted in phantom.
  • the proximal edge of slit (46) is depicted in phantom and designated at reference numeral 46a.
  • the distal edge of slit (26) (upon exit face (23), Fig. 5B) is depicted in phantom and designated at reference numeral 26a.
  • the proximal and axial portion of slit (26) (upon flat surface (25), Figures 4 and 5A) is depicted in phantom and designated at reference numeral 26b.
  • the slits (26, 46) are also stretched by the structure of the respective positioning protrusions (32, 52) in relation to the respective positioning slots (34, 54). This also means that the overall insertion resistance, which previously came from the friction of the medical device (120) passing through the slits (26, 46), of the hemostasis valve (10), is reduced.
  • the back pressure of blood acts against the exit face (43) of the distal valve gasket (40). Due to the structural features of the present hemostasis valve (10), including specifically its relative thinness where medical devices pass through, the proximal valve gasket (20) and the distal valve gasket (40) are maintained substantially in contact during the insertion of elongated medical devices, forming a seamless sealing pair with reduced insertion resistance.
  • the axially rigid structural features of the hemostasis valve (10) When retracting a catheter during the catheterization procedure, the axially rigid structural features of the hemostasis valve (10) also self-adjust the deformation of the valve (10) primarily in a radial direction.
  • the hemostasis valve (10) Due to these structural features of the hemostasis valve (10) and the difference in the thinness of the proximal valve gasket (20) and the distal valve gasket (40) at the specific location where the medical device (120) passes through, the deformations of the proximal valve gasket (20) and distal valve gasket (40) are primarily in a radial direction instead of an axial direction during both insertion and retraction of the elongated cylindrical medical device. Also, because the hemostasis valve (10) occupies approximately the same amount of space in the valve housing (90) prior to, during, and after the insertion and retraction of the elongated cylindrical medical device, seepage of air into the blood stream is prevented. With the hemostasis cannula assembly (70) in place, it is possible to insert medical devices having a wide range of diameters with ease.
  • the elongated cylindrical medical device (120) is inserted through the circular opening (84) in the cap (80) and into the hemostasis valve (10). If the medical device (120) is inserted slightly off center it will be guided by the conical receiving area or guiding cone (22) to the guiding hole (24) of the proximal valve gasket (20). The medical device (120) is then advanced into the slit (26) of the proximal valve gasket (20), into the slit (46) and out of the guiding hole (44) of the distal valve gasket (40). After exiting from the hemostasis valve (10), the medical device (120) is advanced through the introducer sheath (100) and into the blood vessel.
  • any blood which flows between the sheath (100) and the medical device (120) up into the interior of the valve housing (90) is prevented from escaping to the exterior due to the sealing action of the pair of slits (26, 46) and proximal valve gasket (20) and distal valve gasket (40) of- the hemostasis valve (10) around the body of the medical device (120).

Claims (14)

  1. Valve hémostatique (10) comprenant un joint de valve proximal (20) contenant une fente (26) et un joint de valve distal (40) contenant une fente (46), une encoche de positionnement (34) dans le joint de valve proximal (20) et une saillie de positionnement (52) dans le joint de valve distal (40), caractérisée en ce que la saillie de positionnement (52) du joint de valve distal (40) s'adapte à l'intérieur de l'encoche de positionnement (34) du joint de valve proximal (20) et dans laquelle lorsque la saillie de positionnement (52) est placée à l'intérieur de l'encoche de positionnement (34), une rotation axiale du joint de valve proximal (20) par rapport au joint de valve distal (40) est limitée.
  2. Valve hémostatique (10) selon la revendication 1, dans laquelle le joint de valve distal (40) comprend en outre un disque essentiellement aplati et un anneau circulaire bombé (50) sur une face distale (43) dudit disque essentiellement aplati.
  3. Valve hémostatique selon l'une quelconque des revendications 1 ou 2, dans laquelle le joint de valve proximal (20) et le joint de valve distal (40) sont de la même forme.
  4. Valve hémostatique (10) selon l'une quelconque des revendications 1 à 3, dans laquelle le joint de valve proximal (20) comprend en outre une seconde encoche de positionnement (34), dans laquelle le joint de valve distal (40) comprend en outre une seconde saillie de positionnement (52) et dans laquelle le diamètre interne des saillies de positionnement (52) est inférieur au diamètre des encoches de positionnement (34).
  5. Valve hémostatique (10) selon la revendication 4, dans laquelle les deux saillies de positionnement (52) sont à environ 180 degrés l'une de l'autre sur un bord extérieur (49) du joint de valve distal (40).
  6. Valve hémostatique (10) selon la revendication 5, dans laquelle la fente (46) du joint de valve distal (40) se trouve entre les deux saillies de positionnement (52).
  7. Valve hémostatique selon l'une quelconque des revendications 1 à 6, dans laquelle le joint de valve proximal (20) comprend en outre une zone de réception conique (22) et un trou de guidage (24) en communication avec la fente (26), et dans laquelle le joint de valve distal (40) comprend en outre une zone de réception conique (42) et un trou de guidage (44) en communication avec la fente (46) du joint de valve distal (40).
  8. Valve hémostatique (10) selon l'une quelconque des revendications 1 à 7, dans laquelle la fente (26) du joint de valve proximal (20) décrit un angle d'environ 5 à environ 70 degrés par rapport à une ligne perpendiculaire partant d'une surface aplatie du joint de valve (20).
  9. Valve hémostatique selon l'une quelconque des revendications 1 à 8, dans laquelle l'épaisseur (60) de la fente (26) du joint de valve proximal (20) est inférieure à environ 40 % de l'épaisseur (64) du joint de valve proximal (20) entre ses faces d'entrée (21) et de sortie (23).
  10. Ensemble cathéter hémostatique (70) comprenant :
    un logement de valve s'étendant longitudinalement (90) ayant une première ouverture et une chambre longitudinale centrale communiquant avec une seconde ouverture ;
    un bouchon (80) fixé au logement de valve (90) enfermant la première ouverture du logement de valve (90) et offrant une ouverture pour permettre l'insertion d'un dispositif médical à l'intérieur de la première ouverture du logement (90) à travers la chambre centrale et à l'extérieur de la seconde ouverture ; et
    une valve hémostatique (10) selon la revendication 1.
  11. Ensemble cathéter hémostatique (70) selon la revendication 10, dans lequel le joint de valve proximal (20) comprend en outre une partie biseautée (28) et dans lequel la partie biseautée (28) forme un espace entre la valve hémostatique (10) et une surface interne du logement de valve (90) lorsque la valve hémostatique (10) est présente dans le logement de valve (90).
  12. Ensemble cathéter hémostatique (70) selon l'une quelconque des revendications 10 ou 11, dans lequel le bouchon (80) lorsqu'il est fixé au logement de valve (90) met la valve hémostatique (10) sous compression de telle sorte que l'épaisseur de la valve hémostatique (10) soit comprimée d'au moins 2 %.
  13. Ensemble cathéter hémostatique (70) selon l'une quelconque des revendications 10 à 12, dans lequel lors de l'introduction d'un dispositif médical à travers la valve hémostatique (10), une face distale (23) du joint de valve proximal (20) et une face proximale (41) du joint de valve distal (40) restent en contact lorsque le dispositif médical est inséré à travers la valve hémostatique (10).
  14. Ensemble cathéter hémostatique (70) selon l'une quelconque des revendications 10 à 13, dans lequel l'épaisseur (60) de la fente (26) du joint de valve proximal (20) est inférieure à environ 40 % de l'épaisseur (64) du joint de valve proximal (20) entre ses faces d'entrée (21) et de sortie (23).
EP01946796A 2000-01-25 2001-01-18 Valve hemostatique Expired - Lifetime EP1250171B1 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US09/491,221 US6551283B1 (en) 2000-01-25 2000-01-25 Hemostasis valve
US491221 2000-01-25
US734391 2000-12-11
US09/734,391 US6632200B2 (en) 2000-01-25 2000-12-11 Hemostasis valve
PCT/US2001/001588 WO2001054763A2 (fr) 2000-01-25 2001-01-18 Valve hemostatique

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EP1250171A2 EP1250171A2 (fr) 2002-10-23
EP1250171B1 true EP1250171B1 (fr) 2004-09-29

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EP (1) EP1250171B1 (fr)
JP (1) JP4940526B2 (fr)
AT (1) ATE277665T1 (fr)
CA (1) CA2397432C (fr)
DE (1) DE60105973T2 (fr)
WO (1) WO2001054763A2 (fr)

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CA2397432C (fr) 2009-04-07
US6632200B2 (en) 2003-10-14
JP2003520652A (ja) 2003-07-08
DE60105973T2 (de) 2005-10-06
EP1250171A2 (fr) 2002-10-23
JP4940526B2 (ja) 2012-05-30
DE60105973D1 (de) 2004-11-04
ATE277665T1 (de) 2004-10-15
US20020010425A1 (en) 2002-01-24
CA2397432A1 (fr) 2001-08-02
WO2001054763A2 (fr) 2001-08-02
WO2001054763A3 (fr) 2001-11-29

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